Health Care Headlines

The Department of Justice said on Thursday that global pharmaceutical company Pfizer, Inc. settled allegations that it used a foundation as a conduit to pay the copays of Medicare patients taking three Pfizer drugs, in violation of the False Claims Act, and will pay $23.85 million to resolve the claims. Under the Anti-Kickback Statute, pharmaceutical companies are prohibited from offering, directly or indirectly, any payment-which includes paying patients' copay obligations-to induce Medicare patients to purchase the company's drugs. "According to the allegations in today's settlement agreement," said United States Attorney Andrew E. Lelling, "Pfizer knew that the third-party foundation was using Pfizer's money to cover the co-pays of patients taking Pfizer drugs, thus generating more revenue for Pfizer and masking the effect of Pfizer's price increases." Pfizer settled allegations only; there was no determination of liability.

Shares of Recro Pharma Inc. lost more than half their value in premarket trade Thursday, after the pharmaceutical company said it received a complete response letter (CRL) from the Food and Drug Administration regarding its new drug application (NDA) for its non-opioid pain treatment. The CRL says that although phase 3 trials of IV meloxicam met primary endpoints, the FDA said it could not approve the NDA in its current form because data from selective secondary endpoints suggest the analgesic effect does not meet expectations. In addition, the CRL raised questions related to chemistry, manufacturing and control (CMC) on extractable and leachable data provided in the NDA. "We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and look forward to working with the Agency to find solutions that can contribute to solving the current opioid public healthcare problem," said Chief Executive Gerri Henwood. The stock, which plummeted 53% ahead of the open, had run up 45.1% over the past three months through Wednesday, while the SPDR S&P Pharmaceutical ETF had slipped 2.9% and the S&P 500 had eased 0.5%.
8:45 a.m. Today8:45 a.m. May 24, 2018

Health Care Headlines

As Ireland gears up for a historic referendum on abortion on May 25, there are growing concerns that campaigners are resorting to some of the same tactics used in the U.S. presidential election and Brexit vote to win over undecided voters.

Medical supplies distributor McKesson Corp. said Thursday it had a net loss of $1.146 billion, or $5.58 a share, in its fiscal fourth quarter to March 31, after a profit of $3.588 billion, or $16.76 a share, in the year-earlier period. The loss was driven primarily by non-cash goodwill and long-lived asset impairment charges in the company's European and Canadian retail businesses, which were partially offset by benefits related to the December tax revamp. Adjusted per-share earnings came to $3.49, below the FactSet consensus of $3.56. Revenue rose to $51.6 billion from $48.7 billion, topping the FactSet consensus of $51.4 billion. The company said it expects adjusted EPS of $13.00 to $13.80 for fiscal 2019, which compares with a current FactSet consensus of $13.37. The board has approved an additional share buyback authorization of $4.0 billion. Shares were not yet active premarket, but have fallen 5.6% in 2018 to date, while the S&P 500 has gained 2.2%.

Medtronic PLC said Thursday it had net income of $1.460 billion, or $1.07 a share, in its fiscal fourth quarter to April 27, up from $1.163 billion, or 84 cents a share, in the year-earlier period. Adjusted per-share earnings came to $1.42, ahead of the FactSet consensus of $1.39. Revenue rose 2.9% to $8.144 billion, also ahead of the FactSet consensus of $7.999 billion. U.S. revenue of $5.187 billion accounted for 52% of overall revenue. The company set guidance for fiscal 2019, saying it expects adjusted EPS of $5.10 to $5.15, compared with a current FactSet consensus of $5.14. Shares were not yet active premarket, but have gained 5.6% in the year so far, while the S&P 500 has gained 2.2%.

Facebook’s latest problem has put the spotlight on data protection and big tech. Here’s what’s the EU’s General Data Protection Regulation, due Friday, lays down — including fines potentially in the billions of dollars.

The Food and Drug Administration issued a warning early Wednesday about over-the-counter teething products that contain the pain reliever benzocaine, saying the products were unsafe and asking the companies that make them to stop. Affected products include those sold by Pfizer's Anbesol line , Church & Dwight's Orajel and Baby Orajel , Reckitt Benckiser's Cepacol , Prestige Brands' Chloraseptic , privately-held Beutlich Pharmaceuticals' Hurricaine and Colgate-Palmolive's Orabase , along with generic products and those made by store brands. Benzocaine can cause a life-threatening condition called methemoglobinemia, which reduces the amount of oxygen carried through the blood. There have been an estimated more than 400 cases of methemoglobinemia connected to benzocaine since 1971, 119 of which occurred in the last decade, according to the FDA. There's also a lack of evidence that these benzocaine products work for teething, FDA Commissioner Scott Gottlieb said. The regulator is also asking companies to add warnings to other oral health products that use benzocaine, as well as prescription local anesthetics. Benzocaine is a common ingredient in cough drops and products for oral ulcers. The FDA also warned consumers earlier this year against using homeopathic teething tables, due to the presence of the toxic substance belladonna.

Intraday Data provided by SIX Financial Information and subject to terms of use. Historical and current end-of-day data provided by SIX Financial Information. All quotes are in local exchange time. Real-time last sale data for U.S. stock quotes reflect trades reported through Nasdaq only. Intraday data delayed at least 15 minutes or per exchange requirements.